Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia

Phase 3RecruitingNCT06802718

Peking University People's Hospital96 enrolled

Overview

This research focuses on a prospective, randomized, controlled trial of "Interferon-alpha as maintenance therapy for favorable-risk acute myeloid leukemia." By fully utilizing prospective, randomized, controlled clinical trial and studying the negative conversion of MRD and the survival of favorable-risk AML patients, it aims to explore the efficacy and safety of Interferon-alpha in the maintenance treatment of favorable-risk AML and identify effective measures to prevent relapse, thereby improving the survival of favorable-risk AML patients. The primary endpoint is the negative conversion of MRD at 6 months. The secondary endpoints include the 2-year cumulative incidence of relapse, 2-year event-free survival (EFS), 2-year overall survival (OS), and safety.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 18-70 years old (including 18 and 70 years old) with newly diagnosed favorable-risk AML (2022 ELN risk group classification). * Achieved CR1 after 1-2 cycles of standard chemotherapy. * Completed 4-6 cycles of consolidation chemotherapy (including at least 2 cycles of high-dose Cytarabine HDAC regimem). * At the end of consolidation treatment, bone marrow examination confirmed in CR1, flow cytometry MRD negative, but molecular MRD genes (RUNX1:: RUNX1T1, NPM1, and CBFb:: MYH11) decreased by \> 3 log, but still detectable. * Performance status score of 0-2 (ECOG). * Liver function: ALT and AST ≤ 2.5 times the upper limit of normal, bilirubin ≤ 2 times the upper limit of normal. * Kidney function: Creatinine ≤ 1.5 times the upper limit of normal. Exclusion Criteria: * Acute promyelocytic leukemia (APL). * AML with normal karyotype and bZIP intramolecular mutations in CEBPA. * ≥ CR2 status. * Patients strongly demanding transplantation, and with indications for transplantation but not eligible for transplantation. * Uncontrolled active infection. * Severe organ dysfunction. * Pregnancy. * Unwillingness to undergo interferon treatment. * Previous hyperthyroidism or hypothyroidism. * Participation in other clinical trials within one month.